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NCT05812274 | NOT YET RECRUITING | Non Small Cell Lung Cancer


Apricity CARE to Improve ICI Outcomes of Ethnic/Racial Minority NSCLC Patients
Sponsor:

Columbia University

Information provided by (Responsible Party):

Brian Henick, MD

Brief Summary:

The purpose of this trial is to study the effectiveness of the AprictyRxTM care service to improve treatment outcomes of ethnic/racial minority N.S.C.L.C. patients receiving standard of care immunotherapy, and reduce the frequency of healthcare system interactions.

Condition or disease

Non Small Cell Lung Cancer

Intervention/treatment

Apricity C.A.R.E. Program for Cancer Adverse events Rapid Evaluation

Phase

NA

Detailed Description:

Immune checkpoint inhibitors (I.C.I.) targeting the PD-1/PD-L1 axis have changed the treatment landscape of non-small cell lung cancer (N.S.C.L.C.). After demonstrating improved efficacy and tolerability compared to standard chemotherapy in several large clinical trials, these novel drugs are now F.D.A. approved in multiple treatment settings. With the increase in I.C.I. use, the incidence of immune-related adverse effects (irAEs) has also risen, occurring in up to 16% of ICI-treated patients. Prompt recognition and timely management are necessary to avert potential poor outcomes from direct toxicity and/or early treatment discontinuation. However, rapid adoption of I.C.I.s may limit healthcare providers' experience and comfort with managing important irAEs. Additionally, existing barriers to access care that disproportionately impact racial and ethnic minority patients may amplify the inability to manage patients on I.C.I.s effectively. Using technologically-enabled health interventions in a culturally competent manner can improve access to health care resources and reduce health disparities. These platforms need to be optimized at the literacy level of underserved minority communities and can be adapted to meet the community's needs. Recently, technology-enabled services focused on patient-reported outcomes have garnered growing interest in oncology.

Study Type : INTERVENTIONAL
Estimated Enrollment : 280 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : A Phase IV Study of Apricity C.A.R.E. Program for Cancer Adverse Events Rapid Evaluation to Improve Treatment Outcomes of Ethnic/Racial Minority Non-small Cell Lung Cancer (NSCLC) Patients Receiving Immunotherapy
Actual Study Start Date : 2023-04
Estimated Primary Completion Date : 2025-08
Estimated Study Completion Date : 2025-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age≥ 18 years
  • * Confirmed NSCLC diagnosis
  • * Prescribed treatment with immune-checkpoint inhibitor, including in combination with chemotherapy
  • * Ability to understand and the willingness to sign a written informed consent document
  • * Self-identification as a member of an ethnic minority or underserved population.
Exclusion Criteria
  • * An individual with presence of any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study.
  • * Patients enrolled in other interventional clinical trials at the time of screening will be excluded.

Apricity CARE to Improve ICI Outcomes of Ethnic/Racial Minority NSCLC Patients

Location Details

NCT05812274


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, New York

Montefiore Health Center

New York, New York, United States, 10029

Not yet recruiting

United States, New York

Mount Sinai School of Medicine

New York, New York, United States, 10029

Not yet recruiting

United States, New York

NYU Medical Center

New York, New York, United States, 10029

Not yet recruiting

United States, New York

Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer Center

New York, New York, United States, 10032

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